The purpose of this research study is to evaluate the effects (good and bad) of supplementation with Glutamine to that of a placebo (L-alanine), on your child and their Short Bowel Syndrome. Researchers are doing this study to see if the addition of Glutamine to oral/tube feeding (nutrition therapy) will work better by preventing bloodstream infections, improving growth, and/or changing the make-up of bacteria in your child's intestine. Glutamine is approved by the FDA for use in adults with Short Bowel Syndrome. In this study, the investigators will be assessing how well Glutamine affects Short Bowel Syndrome in children.

0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)

Other Name: NutreStore

Placebo Comparator: L-alanine

Dietary Supplement: L-alanine

0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)

No Intervention: Healthy Control

Detailed Description:

This is a double-blind, randomized placebo-controlled pilot study to investigate the efficacy of enteral glutamine (GLN) supplementation in 36 infants, ≤ 12 months of age with parenteral nutrition (PN)-dependent short bowel syndrome (SBS) due to massive small bowel resection for NEC and/or atresia on improving weaning of PN and preventing infections. The investigators intend to evaluate the effect of enteral feeding and GLN supplementation on the gut bacteria. The investigators will also recruit 12 age-matched controls to evaluate the normal gut bacteria.

Eligibility

Ages Eligible for Study:

6 Weeks to 12 Months

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria for Controls:

Less than or equal to 12 months of age

Normal small bowel length without any intestinal resection or primary intestinal disease

Not currently on TPN and if ever on TPN this should have been discontinued for at least 4 weeks.

Patients who have undergone small bowel resection due to NEC or intestinal atresia with known small bowel length

Patients who have been PN dependent for more than 42 consecutive days and currently on TPN at time of enrollment

Patients who have the ability to take partial enteral nutrition or breast milk or elemental formula to allow the appropriate dose of glutamine or placebo

Signed informed consent for the use of Glutamine or placebo

Exclusion Criteria for Glutamine and Placebo Group of SBS Patients:

Major congenital or chromosomal anomalies

Inability to tolerate enteral nutrition that will preclude treatment with enteral Glutamine or L-alanine placebo for > 2 weeks

Liver/Intestinal transplantation

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576003